INDIAN DRUG REGULATORY AUTHORITY

As pharmaceutical sector is growing so fast, many companies are producing their products and selling throughout the world. So to control the Drug development, licensing, production of drugs and selling many regulatory agencies are established. 

There are some international regulatory agencies are available like, ICH (International conference on harmonization), WHO (World health organization), PAHO (PAN Americal health organization), WIPO (World intellectual property organization), WTO (World trade organization). Apart from these many countries are develop their own regulatory body like, USFDA(USA), EMEA( European Union), CDSCO(India), MHRA(UK), TGA(Australia), Health Canada (Canada), ANVISA(Brazil), NMPA(China), MCC(South Africa), NAFDAC(Nigeria), PMDA(Japan), NMRA(Srilanka), KFDA(Korea) etc.

Indian Drug Regaulatory Authority

DCGI (Drug Controller General of India)

- DCGI is the head of CDSCO in India. 

 

CDSCO (Central Drug Standard Control Organization)

- Headquarter:- Delhi

- It comes under ministry of health and family welfare, government of India.

- It is national regulatory authority of India.

- It has six zonal offices, four subzonal offices, thirteen port offices and seven laboratories.

Responsibility:- 

As per Drug and cosmetic act 1940, CDSCO is responsible for approval of drugs, conduct of clinical trials, laying down the standard for drugs, control over the quality of imported drugs in the country and coordination with state government for implementation of drug and cosmetic act.

Further CDSCO along with state regulators is jointly responsible for grant of licenses of specialized categories of critical drug such as blood and blood products, I.V. fluids, vaccines and Sera.

Divisons:-

CDSCO has eight divison,

1) BA/BE (Bioavailability/Bioequivalence)

2) Biologics 

3) Clinical Trials

4) Cosmetics

5) DTAB-DCC

6) Drugs

7) International Cell

8) Medical devices and Diagnostics

Applicant has to file the application for approval to the respective devison like, 

a) Application apply through online Sugam portal,

b) Application will be processed by assistant inspector/Drug inspector,

c) Application send to nodal officer for further review,

d) Nodal officer will send the application to DDC(Deputy decision control authority)/JDC(Decision authority)

e) DCGI will grant the applicant through online Sugam portal.

DCGI approval process for drug substance/drug product,

                  Ref. https//cdsco.gov.in












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